Design Quality Specialist

1 week ago

Ottawa, Canada Canadian Blood Services Full time

#HYBRID #LI-SW1

**Job category**: Quality and regulatory affairs
**Job posting ID**: 5630

**Employment status**:Regular full-time
**Position's anticipated start date**: 2024-05-27

**Classification**:PTS/MGT/IT B
**Salary/Rate of pay**:$87,000 - $105,000

**Application deadline**: 2024-03-17
**Application requirements**:

- Your up-to-date resume.
- We recommend you save a copy of the job posting for reference throughout the recruitment process.

**Together, we can make all the difference in the lives of others.**

Be part of a dynamic, collaborative and caring organization committed to saving and improving lives. Thousands of patients depend on us every day for reliable access to safe blood, plasma, stem cells and organs and tissues.

If you are looking for a rewarding experience with a values and mission-driven team, join Canada’s Lifeline and make a meaningful difference.
- We acknowledge that the work of Canadian Blood Services spans many Territories and Treaty areas across the country, and we are grateful for the Traditional Knowledge Keepers and Elders who have guided us in this important work. We recognize the land and waters that have inspired our work and offer gratitude to those Indigenous peoples on whose territory we work, live and play._

**About the role**
Canadian Blood Services is looking for a **regular full-time Design Quality Specialist **to join our dynamic **Quality Assurance** team.

The **Quality Assurance **team is accountable for the systematic efforts taken to assure that all Canadian Blood Services’ products and services delivered to the customer meets expectations of the customer.

**Formula for success**
- Leveraging your skills and experience in regulatory compliance, you will interpret quality by design principles and requirements described in standards, regulations, and/or industry best practices.
- Utilizing your skills in quality by design principles and product/process development, as well as utilizing your collaboration and documentation management skills, you will provide expertise and support for product and process development while working with the process owner to develop, update, and maintain the technical content of design history files.
- Drawing on your collaboration and documentation management skills, you will work with the process owner to develop, update, and maintain the technical content of risk management files.
- Capitalizing on your collaboration and process improvement skills, you will work with the quality management system team in the development, maintenance, and improvement of work instructions, reference materials, and tools required to operationalize the Quality by Design process.
- Utilizing your educational and communication skills, you will educate process teams about quality by design in the context of the quality management system, ensuring roles, responsibilities, and value propositions are understood.
- Employing your interpersonal and leadership skills, you will develop, promote, and facilitate effective working relationships with Canadian Blood Services staff through expertise and guidance, enabling the organization to understand the Quality by Design requirements in biologics manufacturing and clinical services.

**Desired education and skills**
- University Degree in Engineering or Life Sciences or in a relevant discipline from a recognized academic institution, or equivalent work experience. ASQ Certification as a CQA, CQE, or CMQ/OE would be an asset.
- At least 10 years of progressive related experience within a manufacturing (Pharmaceutical, Medical Device, Biologics or related) environment, with at least 5 years of relevant experience in quality assurance and quality by design.
- Ability to generate internal quality documentation such as design specifications, risk management plans, quality plans, validation and verification Protocols and Reports.
- Experience using quality tools and statistical programs (e.g., risk assessment (FMEA), experimental design (DOE) and statistical process control (SPC) is required.
- Strong collaboration skills, with ability to influence and build strong relations and liaise effectively with various business groups.
- Strong organizational skills as well as time management skills essential for project work.
- Effective communication skills including verbal and written skills, with the ability to quickly produce clearly written, well-organized documentation and presentations.

**What we offer you**
- 4 weeks' vacation
- Annual performance award up to 8%
- Comprehensive group health, dental and vision benefits for you and your family
- Defined benefit pension plan
- Employee discounts, wellness program, professional resources

**What you can expect**
- This role will work in a hybrid environment with requirements to be onsite at one of our Canadian Blood Services locations, at minimum 40% of the time.
- Travel requirements - travel will be required to attend team meetings and project commitments.

D

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